Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT04949451
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2021-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Time Restricted Feeding, Muscle, and Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2021-06-25', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body composition', 'timeFrame': 'Change is being assessed at baseline and final day (day 120) of the intervention.', 'description': 'Body composition measured using dual x-ray absorptiometry to determine the ration of lean/fat-free mass to fat mass.'}], 'secondaryOutcomes': [{'measure': 'Whole body protein turnover', 'timeFrame': 'Change is being assessed at baseline and final day (day 120) of the intervention.', 'description': 'Whole body protein turnover will be measured using 15N-alanine'}, {'measure': 'Muscle mass', 'timeFrame': 'Change is being assessed at baseline and final day (day 120) of the intervention.', 'description': 'Muscle mass will be measured using D3-creatine'}, {'measure': 'Body weight', 'timeFrame': 'Change is being assessed at baseline, 4, 8, and 12 weeks.', 'description': 'Body weight will be measured in kilograms.'}, {'measure': 'Sleep', 'timeFrame': 'Change is being assessed at baseline and 12 weeks', 'description': 'Sleep will be assessed using wrist Actigraphy for sleep duration and total time in bed.'}, {'measure': 'Sleep Quality', 'timeFrame': 'Change is being assessed at baseline, 4, 8, and 12 weeks', 'description': 'Sleep quality will be measured using the Pittsburgh Sleep Quality Index survey'}, {'measure': 'Mood', 'timeFrame': 'Change is being assessed at baseline, 4, 8, and 12 weeks', 'description': 'Mood will be assessed using the Profile of Mood States Questionnaire'}, {'measure': 'Grit', 'timeFrame': 'Change is being assessed at baseline, 4, 8, and 12 weeks', 'description': 'Grit will be assessed using the grit questionnaire.'}, {'measure': 'Self-reported physical activity', 'timeFrame': 'Change is being assessed at baseline, 4, 8, and 12 weeks', 'description': 'Physical activity will be measured using the iPAQ survey'}, {'measure': 'Dietary intake', 'timeFrame': 'Change is being assessed at baseline, 4, 8, and 12 weeks', 'description': 'Dietary intake will be measured using weighed, 3-day food records'}, {'measure': 'Fasting glucose', 'timeFrame': 'Change is being assessed at baseline, 4, 8, and 12 weeks', 'description': 'Glucose will be measured as mg/dl'}, {'measure': 'Hand grip', 'timeFrame': 'Change is being assessed at baseline, 4, 8, and 12 weeks', 'description': 'Hand grip will be measured using a dynamometer.'}, {'measure': 'Amino acids and metabolites', 'timeFrame': 'Change is being assessed at baseline, 4, 8, and 12 weeks', 'description': 'Blood will be collected and plasma amino acids and metabolites will be assessed using commercially available kit for amino acid analysis for all circulating amino acids.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight', 'Obesity']}, 'descriptionModule': {'briefSummary': 'Effective nutrition strategies for combatting and/or preventing obesity still need to be identified. This has been the case despite the numerous and different approaches that have been taken. Potential targets for combatting/preventing obesity have been identified, but long-term solutions have not emerged. This study uses time restricted feeding to study the role of dietary protein in obesity prevention and/or treatment. The objectives are to determine the role of skeletal muscle mass as a driver of energy-sensing mechanisms and peripheral signals that regulate appetite and energy intake in overweight and obese adults and to determine the effects of protein timing on muscle mass to regulate appetite and energy intake in overweight and obese adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resides in Northwest Arkansas\n* Age 25-50 years\n* BMI \\> 25\n* All ethnicities\n* Female and male\n\nExclusion Criteria:\n\n* Food allergies\n* Pregnant or breastfeeding\n* Dietary restrictions (e.g. vegetarian, vegan, etc.)\n* Trying to lose weight in last 3 months\n* Pre-existing health conditions related to obesity (e.g. cardiovascular disease, diabetes, hypertension)\n* Prescription medications related to heart disease or type 2 diabetes\n* Fear of needles\n* Smoker or vaping\n* Currently taking protein supplements or other nutritional supplements which may interfere with study outcomes\n* Consumes \\>4 alcoholic beverages per week'}, 'identificationModule': {'nctId': 'NCT04949451', 'acronym': 'TRIMM', 'briefTitle': 'Time Restricted Feeding, Muscle, and Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas, Fayetteville'}, 'officialTitle': 'Time Restricted Feeding Intervention for Muscle and Metabolic Health (TRIMM)', 'orgStudyIdInfo': {'id': 'TRIMM062021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'TRF-C', 'description': 'Follows time restricted feeding protocol.', 'interventionNames': ['Other: Control group - time restricted feeding only']}, {'type': 'EXPERIMENTAL', 'label': 'TRF-P', 'description': 'Follows time restricted feeding protocol, consumes protein supplement', 'interventionNames': ['Dietary Supplement: Whey protein supplement']}, {'type': 'EXPERIMENTAL', 'label': 'TRF-S', 'description': 'Follows time restricted feeding protocol, consumes ketogenic supplement', 'interventionNames': ['Dietary Supplement: Ketogenic aid']}], 'interventions': [{'name': 'Whey protein supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants consume whey protein at the beginning of the eating period.', 'armGroupLabels': ['TRF-P']}, {'name': 'Ketogenic aid', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants consume ketogenic aid upon waking.', 'armGroupLabels': ['TRF-S']}, {'name': 'Control group - time restricted feeding only', 'type': 'OTHER', 'description': 'Time restricted feeding.', 'armGroupLabels': ['TRF-C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72704', 'city': 'Fayetteville', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jamie I Baum, PhD', 'role': 'CONTACT', 'email': 'baum@uark.edu', 'phone': '479-575-4474'}], 'facility': 'University of Arkansas', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}], 'centralContacts': [{'name': 'Jamie Baum, PhD', 'role': 'CONTACT', 'email': 'baum@uark.edu', 'phone': '479-575-4474'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas, Fayetteville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jamie Baum', 'investigatorAffiliation': 'University of Arkansas, Fayetteville'}}}}